Table 6.
Serious adverse events (safety population)
| Dose group | Adverse event | During year after implantation | Severity | Relationship to treatment | Outcome |
|---|---|---|---|---|---|
| Low | Convulsion | 1st | Moderate | None | Resolved |
| Arthralgia | 1st | Moderate | None | Resolved | |
| Meniscus lesion | 2nd | Severe | None | Resolved | |
| Chondropathy | 3rd | Moderate | Unlikely | Resolved | |
| Arthralgia | 3rd | Moderate | Probable | Resolved | |
| Uterine cyst | 3rd | Moderate | None | Resolved | |
| Medium | Syncope | 2nd | Severe | None | Resolved |
| Chondropathy | 3rd | Moderate | None | Not resolved | |
| High | Umbilical hernia | 2nd | Mild | None | Resolved |
| Chondropathya | 2nd | Severe | Probable | Resolved | |
| Arthralgia | 3rd | Moderate | None | Resolved |
aTwo episodes in the same patient